Recruiting

Observational Study

Sponsor:

University of Chicago

Code:

NCT05608694

Conditions

Prostate Cancer Screening

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prostate MRI

Study Details

Brief summary:

The purpose of this study is to determine whether or not Magnetic Resonance Images (MRI) will identify high-grade cancers earlier and more frequently in men at high risk of developing prostate cancer.

Conditions

Prostate Cancer Screening

Study ID

NCT05608694

Start date

Mar 2, 2022

Status verified date

Feb, 2026

Completion date

Mar 1, 2039

Anticipated

Primary completion date

Mar 1, 2037

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male age 18 and older
  • No known history of prostate cancer
  • No previous prostate resection or ablation (e.g. TURP, photovaporization)

Exclusion Criteria:

  • Unable to tolerate MRI due to metal fragments or claustrophobia
  • Lack of a rectum
  • Hip arthroplasty

Study Design

Enrollment

250 participants

Anticipated

Allocation

Non randomized

Intervention Model

Factorial

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: High Risk- Positive Germline Mutation (n=40):

Men who harbor known germline mutations that have been associated with an increased risk of prostate cancer and aggressive disease (e.g. BRCA2, ATM, PALB2, etc.) with or without a known family history of prostate cancer.

other: High Risk- High GRS (n=40):

Men who harbor significantly increased disease risk based upon genetic risk score (GRS) value >1.5 with or without a known family history of prostate cancer.

other: High Risk- Family History (n=45):

Men with a family history of prostate cancer in at least one sibling, father, uncle, or grandfather but no known increased genetic risk of prostate cancer (has no pathogenic or likely pathogenic mutation along with a low genetic risk score (GRS<1.5).

other: Low Risk (n=125):

No known germline mutation, low genetic risk score (GRS <1.5), and no known family history of prostate cancer.

Interventions

Prostate MRI

Group placement is determined by GRS score, Family history, and germline testing

Primary outcome measure

  • Proportion of patients with high grade prostate cancer detection. [ Time Frame: Every 3 years up to 15 years ]

Central Contacts and Locations

Central contacts

Scott Eggener, MD

7737021001seggener@surgery.bsd.uchicago.edu

Teresa Barry

tbarry@bsd.uchicago.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Scott Eggener, MD

773-702-1001seggener@surgery.bsd.uchicago.edu

Teresa Barry

7737025681tbarry@bsd.uchicago.edu

NorthShore University Health System - Glenbrook Hospital

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Pooja Talaty

ptalaty@northshore.org

Svetlana Brumer

sbrumer@northshore.org

Principal Investigator:

Brian Helfand, MD

More Information

Sponsor

University of Chicago

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-03-02.